The following data is part of a premarket notification filed by Jk-holding Gmbh with the FDA for Ergoline Vitality Total Light 3, Planet Fitness 50/4 Tlt By Ergoline, Planet Fitness 42/3 Tlt By Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 Hlt By Ergoline, Planet Fitness 46/3 Hlt By Ergoline, Erg.
| Device ID | K220500 |
| 510k Number | K220500 |
| Device Name: | Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT By Ergoline, Planet Fitness 42/3 TLT By Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT By Ergoline, Planet Fitness 46/3 HLT By Ergoline, Erg |
| Classification | Booth, Sun Tan |
| Applicant | JK-Holding GmbH Koehlershohner Strasse 60 Windhagen, DE 53578 |
| Contact | Juergen Gerstenmeier |
| Correspondent | Juergen Gerstenmeier JK-Holding GmbH Koehlershohner Strasse 60 Windhagen, DE 53578 |
| Product Code | LEJ |
| CFR Regulation Number | 878.4635 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-22 |
| Decision Date | 2022-07-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EJKP100003865A0 | K220500 | 000 |
| EJKP100003892A0 | K220500 | 000 |
| EJKP100003784A0 | K220500 | 000 |
| EJKP100003785A0 | K220500 | 000 |
| EJKP100003810A0 | K220500 | 000 |
| EJKP100003814A0 | K220500 | 000 |
| EJKP100003898A0 | K220500 | 000 |
| EJKP100003786A0 | K220500 | 000 |
| EJKP100003811A0 | K220500 | 000 |
| EJKP100003813A0 | K220500 | 000 |
| EJKP100004042A0 | K220500 | 000 |